Case Study: Amici Pharmaceuticals achieves DSCSA compliance and scalable serialization with Systech UniTrace

Track & trace partner of choice for virtual manufacturer

Amici Pharmaceuticals is a US-based virtual generic pharmaceutical company marketing multiple product families that needed a scalable serialization and traceability strategy when the DSCSA came into effect. As a small, resource‑constrained virtual manufacturer facing evolving regulatory requirements, Amici chose Systech and its UniTrace traceability platform (with later deployment of Systech’s Verification Router Service) to avoid building extensive in‑house serialization infrastructure.

Systech implemented UniTrace and VRS, integrating with Amici’s CMOs and trading partners to provide rapid, scalable serialization, saleable‑returns verification, and exceptions management. The solution let Amici serialize and exchange data well ahead of DSCSA deadlines, streamline inventory handling via UniTrace alerts, speed processing and distribution to reduce supply‑delay penalties, and lower total cost of ownership while cutting internal resource demands. Systech’s support and CMO relationships also strengthened partner ties (for example, with McKesson) and established a framework for ongoing compliance as regulations evolve.

Amici Pharmaceuticals

Amanda Samojedny

Vice President of Operations